CLINICAL PHARMACOLOGY

Microbiology: The sulfonamides are bacteriostatic agents and the spectrum of activity is similar for all. Sulfonamides inhibit bacterial synthesis of dihydrofolic acid by preventing the condensation of the pteridine with aminobenzoic acid through competitive inhibition of the enzyme dihydropteroate synthetase. Resistant strains have altered dihydropteroate synthetase with reduced affinity for sulfonamides or produce increased quantities of aminobenzoic acid.

Sensitizations may recur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other serious reaction, discontinue use of this preparation.

PRECAUTIONS

General: Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to sulfonamides may also develop.

Ophthlamic ointments may retard corneal wound healing.

The effectiveness of sulfonamides may be reduced by the para-aminobenzoic acid present in purulent exudates.

Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur.

At the first sign of hypersensitivity, increase in purulent discharge, or aggravation of inflammation or pain, the patient should discontinue use of the medication and consult a physician (see WARNINGS).

Information for patients: To avoid contamination, do not touch tip of container to eye, eyelid or any surface.

Carcinogenesis , Mutagenesis , Impairment of Fertility: No studies have been conducted in animals or in humans to evaluate the possibility of these effects with ocularly administered sulfacetamide. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term oral administration of sulfonamides has resulted in thyroid malignancies in these animals.

Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with sulfonamide ophthalmic preparations. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamides. There are no adequate and well controlled studies of sulfonamide ophthalmic preparations in pregnant women and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. This product should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for the development of kernicterus in neonates, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in children below the age of two months have not been established.

Adverse Reactions

Bacterial and fungal corneal ulcers have developed during treatment with sulfonamide ophthalmic preparations.

The most frequently reported reactions are local irritation, stinging and burning.

DOSAGE AND ADMINISTRATION

For conjunctivitis and other superficial ocular infections:

Solution: Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.

For Trachoma:

Solution: Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

HOW SUPPLIED

Sulfacetamide Sodium Ophthalmic Solution, USP 30%

NDC 17478-242-12 15 mL dropper bottle, box of one.

Sulfacetamide Sodium Ophthalmic Solution, USP 10%

NDC 17478-221-12 15 mL dropper bottle, box of one.

STORAGE: Store between 2° and 30°C (36° to 86°F). Store away from heat.

Sulfonamide solution, on long standing will darken in color and should be discarded.

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